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510(k) K894517

FPR AMIKACIN KIT by Colony Laboratories, Inc. — Product Code KLQ

K894517 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR AMIKACIN KIT". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. Colony Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Amikacin
Device Class
Class II
Regulation Number
862.3035
Review Panel
TX
Submission Type

Other clearances by Colony Laboratories, Inc.

  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (September 25, 1989)
  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (September 25, 1989)
  • K894521 — FPR DIGOXIN KIT (September 25, 1989)
  • K894530 — FPR THEOPHYLLINE CALIBRATOR KIT (September 18, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K894531 — FPR TOBRAMYCIN KIT (September 1, 1989)

Other clearances for product code KLQ

  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K033884 — RANDOX AMIKACIN (June 9, 2004)
  • K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM (February 9, 1996)
  • K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET (August 9, 1990)
  • K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (June 25, 1985)
  • K843211 — AMIKACIN ANALYTICAL TEST PACK ACA (September 12, 1984)
  • K841161 — IMMPULSE AMIKACIN ASSAY REAGENTS (May 2, 1984)
  • K840193 — EMIT QST AMIKACIN ASSAY (March 23, 1984)
  • K832336 — STRATUS AMIKACIN FLUOROMETRIC (August 31, 1983)
  • K822657 — EMIT-AMD AMIKACIN ASSAY (September 28, 1982)

FDA data resources